COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: COVID-19 Recurrent; Chemotherapy; Vaccination; Immune Checkpoint Inhibitor; Lung Cancer; Antibody

Treatments: Biological: Any Chinese government-recommended COVID-19 booster vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06168032

K4846

Details and patient eligibility

About

A prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated COVID-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against XBB) and those who refuse. Meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against COVID-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.

Full description

A single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic COVID-19 infection and status including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. For antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.

Enrollment: 1,224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who agree to participate in the trial and sign the informed consents.
2. Male or female, ≥18 years old.
3. Diagnosed of lung carcinoma by histological and cytological examinations.
4. Undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy.
5. Recorded history of COVID19 infection.
6. Sufficiently functional organs.
7. Eastern Cooperative Oncology Group performance score (PS) ranging from 0 to 2.

Exclusion criteria

1. Life expectance less than 3 months.
2. Less than 3 months since last confirmed COVID-19 infection.
3. Patients unable to return the hospital for follow-up.
4. Patients allergic to COVID-19 vaccine.
5. Patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,224 participants in 2 patient groups

Vaccinated group

Experimental group

Description:

Any booster doses(without limitations in the subtypes or brands of the vaccines) recommended or approved by Chinese government will be administered once in the 6th months after latest confirmed COVID-19 infection and during the following 6 months, any conditions including repeated COVID19 infection, critical and/or severe conditions and all-cause death will be recorded.

Treatment:

Biological: Any Chinese government-recommended COVID-19 booster vaccine

Non-vaccinated group

No Intervention group

Description:

Patients unwilling to get vaccination will be allocated into these group, but any events including recurrent COVID19 infection, critical and/or severe conditions and all-cause death will be recorded in the following six months.